Vaccination Against MSI Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title: Phase I/IIa Study of Immunization With Frameshift Peptides Administered With Montanide® ISA-51 VG in Patients With Advanced MSI-H Colorectal Cancer

Status Completed

Clinical Trial Summary

Patients with advanced microsatellite unstable (MSI-H) colorectal cancer will be vaccinated with three so called frame shift peptides (FSPs), AIM2(-1), HT001(-1) and TAF1B(-1) combined with Montanide® ISA-51 VG. By this, an immune response directed against MSI-induced FSPs that are shared by the majority of MSI-H colorectal cancers can be induced. The aim is to show that vaccination against MSI-induced FSPs is safe and can induce or enhance immune responses against MSI-H colorectal cancer-associated antigens.

Clinical Trial Description

The present study is initiated to evaluate vaccination with MSI-specific FSPs in patients with MSI-H colorectal cancer. Specifically, the present study aims at the following questions:

• Evaluation of potential toxicity of the FSP AIM2(-1), HT001(-1), TAF1B(-1)

• Evaluation of the immune response in patients with advanced MSI-H colorectal cancer before vaccination and after vaccination with the FSP AIM2(-1), HT001(-1), TAF1B(-1)

In this context, the present study shall demonstrate whether application of FSP in a vaccination approach is associated with the induction of peptide-related toxicity. Hence, the study marks the first step towards the application of FSP in humans, as it provides information on the safety of FSP as vaccination agents for the first time. Moreover, the study shall provide initial information, whether vaccination with FSP can induce FSP-specific immune responses in patients with MSI-H colorectal cancer. Thus, it shall provide information, whether FSPs AIM2(-1), HT001(-1), and TAF1B(-1) have the potential to elicit peptide-specific immune responses and therefore represent suitable targets for the induction of tumor antigen-specific immune responses in patients with MSI-H tumors.

The present study marks an important milestone towards a potential application of MSI-specific FSP as therapeutic agents in the management of patients with MSI-H tumors, particularly patients with MSI-H colorectal cancer. Long-term goal of this approach is to develop novel tools for (1) the palliative and/or adjuvant therapy of patients with advanced MSI-H colorectal cancer and (2) the preventive application of FSPs in mutation carriers of the HNPCC/Lynch syndrome. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT01461148
• Study type: Interventional
• Source: Oryx GmbH & Co. KG
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2011
• Completion date: May 2015